Hemispherx says FDA rejects fatigue drug application

February 04, 2013|Reuters

Feb 4 (Reuters) - Hemispherx Biopharma Inc said U.S.regulators had declined to approve its new drug application forAmpligen, its experimental drug for treating chronic fatiguesyndrome, five years after the company first filed for thedrug's approval.

Hemispherx, based in Philadelphia, said it plans to requestan "end-of-review conference" with the Food and DrugAdministration and may submit a formal appeal regarding theregulator's decision.

The FDA said Hemispherx should conduct at least oneadditional clinical trial, complete various nonclinical studiesand perform a number of data analyses, according to a statementfrom the company.

In its Complete Response Letter, the FDA said the submitteddata did not provide substantial evidence of efficacy ofAmpligen for the treatment of chronic fatigue syndrome.

The FDA also said the data did not provide sufficientinformation to determine whether the product was safe for use"due to the limited size of the safety database and multiplediscrepancies within the submitted data."

Hemispherx first applied for approval of Ampligen in October2007.

In November 2009, the FDA had called for at least oneadditional clinical study of Ampligen, including at least 300patients on dose regimens intended for marketing.